Last year Jick and colleagues1 reported a cohort study of 4,665 patients from the Group Health Cooperative (GHC), Seattle, suggesting that presumed spermicide users had infants with a higher rate of malformations than presumed nonusers. They found a twofold increase in major malformations and specific increases for Down's syndrome, limb reduction deformities, and hypospadias. An increase was also noted for neoplasms. The authors themselves considered the data tentative because no well-defined syndrome was found among the infants of users. The diversity of the increased malformations is another strong reason to consider the findings tentative.

There are other reasons to consider the findings tentative or preliminary. One must have reservations about the accuracy with which infants were classified as exposed or unexposed. An infant was considered exposed if his mother had had a prescription filled by the GHC pharmacy within 600 days of birth. Although this definition is free of